Effects of Clinical Pathways for COPD on Patient, Professional, and Systems Outcomes

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Original Research

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Effects of Clinical Pathways for COPD on Patient, Professional, and Systems Outcomes

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A Systematic Review

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Q3

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Christopher T. Plishka, MPH; Thomas Rotter, PhD; Erika D. Penz, MD; Mohammed R. Hansia, MBBCh; Shana-Kay A. Fraser, MBBS, MPH; Darcy D. Marciniuk, MD, FCCP; for the Saskatchewan COPD CPWs Research Group

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COPD has a substantial burden seen in both patient quality of life and healthcare costs. One method of minimizing this burden is the implementation of clinical pathways (CPWs). CPWs bring the best available evidence to a range of health-care professionals by adapting guidelines to a local context and detailing essential steps in care.

BACKGROUND:

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A systematic review was conducted to address the following question: What are the effects of CPWs for COPD on patient-, professional-, and systems-level outcomes? The review used methods outlined by the Cochrane Collaboration. We included all studies that met our operational definition for CPWs and focused on COPD. All studies were evaluated for risk of bias, and all data regarding patient, professional, and systems outcomes were extracted.

METHODS:

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The search strategy identified 497 potentially relevant titles. Of these, 13 studies were included in the review. These studies reported a total of 398 outcomes, with sufficient data for meta-analysis of five outcomes: complications, length of stay, mortality, readmissions, and quality of life. Results showed statistically significant reductions in complications, readmissions, and length of stay but did not show changes in mortality or quality of life.

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CONCLUSIONS:

RESULTS:

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73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89

This systematic review reveals evidence to suggest that CPWs for COPD have the potential to reduce complications, readmissions, and length of stay without negatively influencing mortality or quality of life. However, quality of evidence was generally low. The authors therefore acknowledge that results should be interpreted with caution and note the need for additional research in this area. CHEST 2019; -(-):---

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care map; care pathway; clinical pathway; COPD; CPW; critical pathway; integrated care pathway; systematic review

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KEY WORDS:

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ABBREVIATIONS: AECOPD = exacerbations of COPD; CPW = clinical pathway; EPOC = Cochrane Effective Practice and Organization of Care; MD = mean difference; SGRQ = St. George’s Respiratory Questionnaire AFFILIATIONS: From the College of Pharmacy and Nutrition (Mr Plishka) and Division of Respirology, Critical Care and Sleep Medicine (Drs Penz and Marciniuk), Department of Medicine, Respiratory Research Center, University of Saskatchewan, Saskatoon, SK, Canada; Healthcare Quality Programs (Dr Rotter), School of Nursing, Queen’s University, Kingston, ON, Canada; Saskatchewan Health Authority (Dr Hansia), Saskatoon, SK, Canada; and British Virgin Islands Health Services Authority (Dr Fraser), Road Town, Tortola, British Virgin Islands.

*Collaborators from the Saskatchewan COPD CPWs Research Group are listed in the Acknowledgments. Part of this article has been presented earlier (Plishka C, Rotter T, Kinsman L, et al. Systematic Rev. 2016;5:135). Q4 FUNDING/SUPPORT: The protocol development has been supported Q5 by the Lung Health Institute of Canada. CORRESPONDENCE TO: Christopher T. Plishka, MPH, University of Saskatchewan, E3111 Health Sciences Bldg, 104 Clinic Pl, Saskatoon, SK, Canada S7N 5E5; e-mail: [email protected] Q6 Copyright Ó 2019 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved. DOI: https://doi.org/10.1016/j.chest.2019.04.131

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Background

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Description of the Condition

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COPD is a respiratory disease characterized by progressive, partially reversible airway obstruction and lung hyperinflation.1,2 This leads to progressive shortness of breath, limitation of daily activities, worsening health-related quality of life, and increasingly frequent and severe exacerbations.1 The disease is significantly underdiagnosed,3,4 leading to difficulty in estimating prevalence at both the international and national levels. Estimates for worldwide prevalence of COPD range from 4% to 20%.3 Similar trends can be seen in Canada, where approximately 4% of Canadians self-report as being diagnosed, but estimates based on airflow obstruction suggest a prevalence between 12% and 17% depending on diagnostic criteria.4

115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151

COPD has significant consequences. It is the fourth leading cause of death in Canada5 and the third leading cause of death in the United States.6 In 2009, COPD caused 8 million physician office visits, 1.5 million ED visits, 715,000 hospitalizations, and 133,965 deaths in the United States. In 2010, costs for COPD in the United States were projected to be USD $49.9 billion.7 Exacerbations of COPD (AECOPD) account for most of the morbidity. In Canada alone, the cost of moderate and severe exacerbations has been estimated to be CAD $646 to $736 million per year.8 To minimize the burden of COPD, high-quality guidelines have been developed.1,2,9-14 These guidelines generally specify disease identification through spirometry and management with a combination of smoking cessation, vaccination, pharmacologic therapy, physical activity, pulmonary rehabilitation, prevention, and optimal management of AECOPD.1,15 When implemented, these steps have shown substantial

increases in patient quality of life, as well as a reduction in health-care utilization.16 Although these results are promising, evidence suggests that the creation of guidelines in isolation is inadequate17-19 as passive dissemination of guidelines rarely results in meaningful changes in practice.10,20,21 Estimates across the health-care environment suggest that 30% to 40% of patients do not receive treatments with proven effectiveness,22 although guideline uptake varies across areas of care.23

166 167 168 169 170 171 172 173 174 175 176 177 178 179

Description of the Intervention

One proposed method of minimizing this gap is the implementation of clinical pathways (CPWs). CPWs, also known as “care pathways,” “integrated care pathways,” “critical pathways,” “care plans,” or “checklists,” are tools used by health professionals to guide evidence-based practice and improve the interaction between health services. They bring the best available evidence to a range of health-care professionals by adapting guidelines to a local context and detailing the essential steps in the assessment and care of patients.24,25 Evidence suggests that CPWs are commonly implemented and studied in hospitals.26 However, research analyzing use extent of CPWs in primary care is still underway.27 Evidence exists to support the use of CPWs for certain clinical conditions to change behavior and improve quality of care.18,19,28-30 Less evidence is available to establish the effectiveness of CPWs for the management of COPD. This scenario was shown in a systematic review from 2011 that focused on in-hospital management of AECOPD. This review used a comprehensive search strategy but only included four studies,31 as well as a subgroup analysis from a Cochrane systematic review that included only a single study.26

180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206

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Materials and Methods

Search Strategies

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The current review follows the methodology outlined in a previously published review protocol.32 Methods are based on the guidelines provided by the Cochrane Collaboration.33 For brevity, this section only outlines the authors who completed each task and notes changes from the protocol.32 Due to the nature of this research, ethics approval was not required.

The review used two search strategies outlined in the systematic review protocol that focused on CPWs in primary care and CPWs in hospitals.32 Copies of the search strategy are presented in e-Table 1 and e-Table 2, respectively. We also hand-searched the reference list of a previously conducted Cochrane Effective Practice and Organisation of Care Review (EPOC) group systematic review on the use of CPWs in hospitals.26

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Review Questions and Objectives

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The primary aim of the review was to address the following question: What are the effects of CPWs for COPD on patient-, professional-, and systems-level outcomes?

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2 Original Research

Data Extraction Pairs of two reviewers (C. T. P. and S.-K. A. F., C. T. P. and A. T.) Q7 independently extracted data according to the double data entry method by using a standardized data extraction form developed in

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Microsoft Access. Disagreements were referred to a third author (T. R.).

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decided that all analyses would be conducted by using a random effects model. Analyses were conducted by using the RevMan 5.3 software.34

Risk of Bias Assessment

224

Pairs of two reviewers (C. T. P. and S. F., C. T. P. and A. T.) independently assessed the methodologic quality of all included studies. Unresolved disagreements regarding risk of bias were referred to a third author (T. R.).

225 226 227 228

Meta-Analysis

229

After consultation with a statistician, it was decided that studies would be combined for analysis regardless of study design but that sensitivity analysis based on study design would be conducted when a sufficient number of studies reported on a common outcome. It was further

230 231 232

280

Because all studies using a cluster-randomized controlled trial design conducted analysis at the individual level, rather than on clusters, we reduced the effective sample size based on the guidelines provided by the Cochrane handbook.33 An intracluster correlation coefficient of 0.01 was chosen based on research by Pozo-Rodríguez et al.35 Further, SDs were calculated based on 95% CIs when necessary, as per the recommendations in the Cochrane handbook.33 Calculations are provided in e-Table 3.

235 236 237 239 240 241 242 243 244 245

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Implementation Strategies

Screening

Based on the available literature, we identified 12 evidence-informed implementation strategies appropriate for CPWs. These include: clinician involvement,26,53 evidence-based interventions,26,54 local consensus process,55 creation of an implementation team,26,55 identification of potential barriers to change,26,56,57 identification of practice gaps,26,57 local opinion leader involvement,26,53,56 educational meetings,56 educational outreach,55,56 printed educational materials,55,56 audit and feedback systems,26,56 and reminder systems.26,55,56 These strategies are outlined in e-Appendix 1. Table 1 presents details on the specific strategies used in each study.

Q8

All search hits were screened independently by two reviewers (C. T. P. and A. L.). Initially, titles and abstracts were screened. Eighty-four potentially relevant articles were identified, and full text was retrieved for these articles. Of these, 17 unique titles36-51 representing 13 studies met our inclusion criteria and were included in the review. Details on the screening and inclusion/ exclusion are given in Figure 1. The reason for exclusion of the remaining 68 titles is outlined in e-Table 4. 46

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Titles by Kruis et al and Boland et al were combined because they report different information for the same study and are collectively referred to as Kruis et al.46 Similarly, titles by Casas et al,43 Garcia-Aymerich et al,44 and Hernández et al45 each present unique information from the same study and are collectively referred to as Casas et al.43 Finally, the studies by Lodewijckx et al50 and Vanhaecht et al36 are collectively referred to as Vanhaecht et al.36 When making reference to these studies in text, we cite only the primary publication.

267 268 269 270 271 272 273 274 275

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Results The search regarding CPWs in primary care resulted in 312 potentially relevant search hits, and the search regarding CPWs in hospitals resulted in 257 potentially relevant search hits. Hand-searching identified an additional six potentially relevant articles. Together, this approach resulted in a total of 575 search hits. Of these, 78 were duplicates, leaving 497 potentially relevant hits.

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Missing Information

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Additional information on the country where the study was conducted, health-care setting, urban/rural location, pathway focus, and diagnostic criteria is given in Table 2. Further information on study length, healthcare workers involved, pathway purpose, intervention description, and disease severity is given in e-Table 5.

295 296 297 298 299 300 301 302 303 304 305 307 308 309 310 311 312 313 314

Risk of Bias

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Three studies were rated as having a low overall risk of bias,36,37,47 six were rated as having an overall moderate risk of bias,38,40,42,43,46,48 and four were rated as having an overall serious risk of bias.39,41,49,52 Evidence for each rating is shown in e-Table 5, and ratings for each risk of bias category is given in e-Table 6.

316 317 318 319 320 321 322 323

Study Designs

Outcomes

Six studies used historically controlled designs.40-42,47,49,52 Three studies used cluster randomized controlled trials.36,46,48 Two used randomized controlled trials.37,43 Finally, one study used a nonrandomized controlled design,39 and one used a self-controlled (case series) design.38

Data were extracted for a total of 398 outcomes. Among these, 207 were categorized as patient outcomes, 142 were categorized as professional outcomes, and 49 were categorized as systems/efficiency outcomes. A comprehensive list of outcomes and their noted effects is given in e-Table 7.

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Additional Information

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Identification

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Records identified through database searching (N = 569)

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Additional records identified through other sources (n = 6)

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Records aer duplicates removed (n = 497)

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Screening

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Records screened (n = 497)

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Records excluded (n = 413)

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Full-text arcles assessed for eligibility (n = 84)

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Eligibility

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Full-text arcles excluded, with reasons (n = 67)

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Studies included in qualitative synthesis (n = 13)

355 356 357

410 411 412 413

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414

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print & web 4C=FPO

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Included

358

415

Studies included in quantitative synthesis (meta-analysis) (n = 10)

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Figure 1 – Preferred Reporting Items for Systematic Reviews and Meta-analyses flow diagram.

Q36 Q26

421

367 368 369 370 371 372 373

422

Effects of Interventions

A sufficient number of studies reported comparable data to conduct meta-analysis for five outcomes: complications, readmissions, mortality, length of stay, and quality of life.

374 375 376 377 378 379 380 381 382 383 384 385

420

Complications: Three studies were included in the meta-analysis assessing number of complications.40,47,49 Results of meta-analysis suggest that the odds of complication are 0.37 following implementation of a CPW compared with usual care (OR, 0.37; 95% CI, 0.210.65; P < .001). Because only three studies reported on complications, no sensitivity analysis was conducted. Similarly, the funnel plot was not assessed for reporting bias. A forest plot of the overall meta-analysis is presented in Figure 2.

4 Original Research

Readmissions: Seven studies were included in the metaanalysis assessing readmissions.36,37,40,41,43,47,49 Results of meta-analysis suggest that the odds of readmission are 0.66 following implementation of a CPW compared with usual care (OR, 0.66; 95% CI, 0.49-0.88; P ¼ .005) when assessment was conducted for the longest reported follow-up period. When follow-up was reduced to 30 days, this difference did not reach statistical significance (OR, 0.69; 95% CI, 0.45-1.06; P ¼ .09). However, it should be noted that only four studies reported on readmissions at 30 days36,40,41,47 and that analysis of adjusted data using generic inverse variance analysis showed a statistically significant difference (OR, 0.61; 95% CI, 0.40-0.93; P ¼ .02). When assessing the longest reported follow-up period, sensitivity analysis for studies rated as having an overall

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TABLE 1

] Implementation Strategies

Clinician Involvement

Study

Q28

Evidencebased Interventions

Local Consensus Processes

Implementation Team

Identification of Potential Barriers to Change

Identification of Practice Gaps

Local Opinion Leaders

Educational Meetings

Educational Outreach

Printed Educational Materials

Audit and Feedback

Reminders

x

x

x

x

.

.

.

x

.

.

.

x

Casas et al,43 2006

.

x

.

.

.

.

.

x

x

x

.

.

Farley,52 1995

x

x

x

x

x

x

.

x

.

x

.

. .

Ban et al,

49

2012

Ko 2014

x

x

.

.

.

.

.

.

.

.

.

Ko 2017

.

x

.

.

.

.

.

.

.

.

.

.

Kong 1997

.

x

.

.

.

x

.

.

.

x

.

.

Kruis et al,46 2013

x

x

x

x

.

.

.

x

.

.

x

.

LaRoche 2016

x

x

.

.

.

.

.

.

.

x

.

x

McCarthy 2013

x

x

.

x

.

x

.

x

.

x

.

. .

McManus 2005

x

x

x

.

x

.

.

.

.

.

Santamaria 2004

x

.

.

.

.

.

.

.

.

.

.

.

Smith 2004

x

x

.

.

x

.

.

x

.

x

.

.

Vanhaecht et al,36 2016

x

x

x

x

.

x

.

x

x

.

.

.

Q29

5 497

496

499

498

501

500

502

503

505

504

507

506

509

508

511

510

512

513

515

514

517

516

519

518

521

520

522

523

525

524

527

526

529

528

531

530

532

533

535

534

537

536

539

538

541

540

542

543

545

544

547

546

548

550

549

551

TABLE 2

] Study Characteristics

552 553 554 555 556 557 558 559 560 561

Study

Country

606 Health-Care Setting

607 Urban/Rural

Pathway Focus

Hospital

Urban

Exacerbation

FEV1/FVC < 0.70

Casas et al,43 2006

Belgium, Spain

Community/ hospital

Urban

Maintenance

“Patients presenting with COPD exacerbation”

612

DRG codes

614

52

Farley, 1995

Ko 2014

United States China

Hospital Community/ hospital

Urban Urban

Exacerbation and maintenance Exacerbation and maintenance

565 566 Ko 2017

China

Community/ hospital

Urban

Exacerbation and maintenance

569 570 571 572 574

Kong 1997

United States

Hospital

Urban

Exacerbation

575 576 577

McManus 2005

Ireland

Hospital

Urban

Exacerbation

Santamaria 2004

Australia

Hospital

Urban

Exacerbation and maintenance

FEV1 < 80% predicted

589

Smith 2004

Australia

Hospital

Urban

Exacerbation

ICD-10 discharge codes

590

Vanhaecht et al,36 2016

Belgium, Italy, Portugal

Hospital

Urban/ rural mix

Exacerbation

Hospital admission with diagnosis of COPD exacerbation and GOLD criteria

583 584 585 586 587 588

591 592 593 594 595

625 626 627 628

632

Urban/ rural mix

Exacerbation and maintenance

Urban

Exacerbation and maintenance

ICD-9 discharge codes

Exacerbation

Increased dyspnea, increased sputum volume, or increased sputum purulence

Urban

623 624

GOLD guidelines

Ireland

Hospital

621 622

630

McCarthy 2013

582

Hospital

619 620

Age ($ 45 y), worsened dyspnea, and a diagnosis of exacerbation based on ICD-9 codes

United States

581

617 618

At least two of the major symptoms (increased dyspnea, increased sputum purulence, increased sputum volume) or one major and one minor symptom for at least 2 consecutive days

LaRoche 2016

580

Community

616

At least two of the major symptoms (increased dyspnea, increased sputum purulence, increased sputum volume) or one major and one minor symptom for at least 2 consecutive days

The Netherlands

579

611

615

Kruis et al,46 2013

578

610

613

564

573

609

Malaysia

563

568

Diagnostic Criteria

Ban et al, 2012

49

562

567

608

629 631 633 634 635 636 637 638 Q30

NA

641 642 643 644 645 646 647

DRG ¼ Diagnosis Related Group; GOLD ¼ Global Initiative for Chronic Obstructive Lung Disease; ICD-9 ¼ International Classification of Diseases, Ninth Revision; ICD-10 ¼ International Classification of Diseases, Tenth Revision.

596 597 598 599 600 601 602 603 604 605

639 640

648 649 650 651

low risk of bias36,37,47 showed significantly reduced odds of readmission (OR, 0.62; 95% CI, 0.41-0.94; P ¼ .02). This outcome was mirrored when assessing randomized trials (OR, 0.54; 95% CI, 0.36-0.80; P ¼ .002). However, sensitivity analysis using only pre-post comparisons/ historically controlled studies did not show a significant difference (OR, 0.95; 95% CI, 0.60-1.50; P ¼ .81). Assessment of the funnel plot revealed no evidence of

6 Original Research

reporting bias. A forest plot of the overall meta-analysis is presented in Figure 3. Forest plots for sensitivity analyses are presented in e-Figure 1. Mortality: Six studies were included in the metaanalysis assessing mortality.36,39,41,43,47,49 Results of meta-analysis provided no evidence to suggest that the odds of mortality differed between the CPW group and

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652 653 654 655 656 657 658 659 660

661 662

Study or Subgroup

663

Ban 2012 LaRoche 2016 Santamaria 2004

664 665 666 668 669 670 671 672

print & web 4C=FPO

667

CPW Events Total 14 8 13

95 63 88

Non-CPW Events Total 38 21 19

98 61 90

Weight

OR M-H, Random, 95% CI

38.7% 27.4% 33.9%

0.27 (0.14, 0.55) 0.28 (0.11, 0.69) 0.65 (0.30, 1.41)

Total (95% CI) 246 249 100.0% Total events 35 78 Heterogeneity: τ2 = 0.09; χ2 = 3.12, df = 2 (P = .21); I2 = 36% Test for overall effect: z = 3.45 (P = .0006)

0.37 (0.21, 0.65)

716

OR M-H, Random, 95% CI

717 718 719 720 721 722 723

0.01 0.1 1 10 Favors [Experimental] Favors [Control]

100

724 725 726 727

Figure 2 – Forest plot for complications. CPW ¼ clinical pathway; M-H ¼ Mantel-Haenszel.

673

728

674

the usual care group (OR, 1.10; 95% CI, 0.69-1.78; P ¼ .68). Similarly, there was no evidence of a difference when assessing studies rated as having a low or moderate overall risk of bias (OR, 1.04; 95% CI, 0.641.69; P ¼ .88) or pre-post comparisons/historically controlled studies (OR, 1.44; 95% CI, 0.58-3.59; P ¼ .43). Inspection of the funnel plot revealed no evidence of reporting bias. A forest plot of the overall meta-analysis is presented in Figure 4. Forest plots for sensitivity analyses are presented in e-Figure 1.

675 676 677 678 679 680 681 682 683 684 685

Length of Stay: Six studies were included in the metaanalysis assessing length of stay.36-38,40,47,49 Results of the meta-analysis suggest that length of stay was significantly shorter following implementation of a CPW compared with usual care (mean difference [MD], –1.66; 95% CI, –2.35 to –0.97; P < .001). Sensitivity analysis was conducted based on risk of bias and study design. Three studies were rated as having an overall low risk of bias,36,37,47 and pooled results of these studies failed to show a significant reduction in length of stay (MD, –2.10; 95% CI, –4.38 to 0.17; P ¼ .07). In contrast, sensitivity analysis using only pre-post comparisons/ historically controlled studies40,47,49 mirrored the overall

686 687 688 689 690 691 692 693 694 695 696 697 698 699

results, reaching statistical significance (MD, –1.40; 95% CI, –1.98 to –0.82; P < .001). Visual inspection of the funnel plot for the six included studies did not suggest evidence of reporting bias. A forest plot of the overall meta-analysis is presented in Figure 5. Forest plots for sensitivity analyses are presented in e-Figure 1. Quality of Life: Three studies37,43,46 reported five comparable outcomes regarding quality of life: change in St. George’s Respiratory Questionnaire (SGRQ) total score, change in SGRQ impacts score, change in SGRQ symptoms score, change in SGRQ activities score, and change in Medical Research Council/modified Medical Research Council Dyspnea scale score. However, due to Q9 substantial heterogeneity, results were not pooled for change in SGRQ total score (c2 ¼ 6.76, P ¼ .03, I2 ¼ 70%), change in SGRQ activities score (c2 ¼ 9.30, P ¼ .01, I2 ¼ 78%), or change in Medical Research Council/ modified Medical Research Council Dyspnea Scale score (c2 ¼ 8.71, P ¼ .01, I2 ¼ 77%).

729 730 731 732 733 734 735 736 737 738 739 740 741 742 743 744 745 746 747 748 749 750 751

Results of the meta-analyses showed no difference regarding change in SGRQ impacts score (MD, –1.84; 95% CI, –5.36 to 1.68; P ¼ .30) or SGRQ symptoms

752 753 754

700

755

701

756

702

Study or Subgroup

703

Ban 2012 Casas 2006 Ko 2017 LaRoche 2016 McCarthy 2013 Santamaria 2004 Vanhaecht 2016

704 705 706 707 708 709 711 712 713 714 715

print & web 4C=FPO

710

CPW Events Total 22 33 44 5 7 15 37

95 65 90 74 51 88 125

Non-CPW Events Total 22 62 63 9 6 19 37

98 90 90 68 50 90 105

Weight

OR M-H, Random, 95% CI

16.2% 16.8% 19.1% 6.2% 6.0% 13.4% 22.4%

1.04 (0.53, 2.04) 0.47 (0.24, 0.90) 0.41 (0.22, 0.76) 0.48 (0.15, 1.50) 1.17 (0.36, 3.75) 0.77 (0.36, 1.63) 0.77 (0.44, 1.35)

Total (95% CI) 588 591 100.0% Total events 163 218 Heterogeneity: τ2 = 0.02; χ2 = 6.86, df = 6 (P = .33); I2 = 12% Test for overall effect: z = 2.82 (P = .005)

0.66 (0.49, 0.88)

OR M-H, Random, 95% CI

757 758 759 760 761 762 763 764 765 766 767

0.01 0.1 1 10 Favors [Experimental] Favors [Control]

100

769 770

Figure 3 – Forest plot for readmissions (longest follow-up). See Figure 2 legend for expansion of abbreviations.

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771 772 773 775 776 777 778

782 783 784

print & web 4C=FPO

779 781

2 12 0 1 9 16

Ban 2012 Casas 2006 Kong 1997 McCarthy 2013 Santamaria 2004 Vanhaecht 2016

774

780

CPW Events Total

Study or Subgroup

95 65 16 51 88 139

Non-CPW Events Total 0 14 0 0 8 16

98 90 11 50 90 121

Weight 2.4% 31.5% 2.2% 22.6% 41.3%

460 100.0% 454 Total (95% CI) 38 40 Total events Heterogeneity: τ2 = 0.00; χ2 = 1.92, df = 4 (P = .75); I2 = 0% Test for overall effect: z = 0.41 (P = .68)

OR M-H, Random, 95% CI

826

OR M-H, Random, 95% CI

827 828

5.27 (0.25, 111.17) 1.23 (0.53, 2.87) Not estimable 3.00 (0.12, 75.41) 1.17 (0.43, 3.18) 0.85 (0.41, 1.79)

829 830 831 832 833 834

1.10 (0.69, 1.78)

835 836

0.01 0.1 1 10 Favors [Experimental] Favors [Control]

837

100

838 839

Figure 4 – Forest plot for mortality. See Figure 2 legend for expansion of abbreviations.

840

786

841

787

score (MD, –3.66; 95% CI, –8.35 to 1.02; P ¼ .13). Because only three studies reported on quality of life, no sensitivity analysis was conducted. Similarly, the funnel plot was not assessed for reporting bias. Forest plots for SQRQ impacts score and symptoms score are presented in Figures 6 and 7, respectively.

842

785

788 789 790 791 792 793 794

Subgroup Analysis

795 797 798 799 800 801 802 803 804 805 806 807 808 809 810

843 844 845 846 847 848 849 850

As a result of the data available, subgroup analyses were conducted based on the source of evidence used for pathway development (development including Global Initiative for Chronic Obstructive Lung Disease guidelines or development that did not include these guidelines) and the number of implementation strategies used (six or more strategies or five or fewer strategies). Subgroup analysis was considered based on country, year of publication, and context (hospital, primary care, or both), but there was either too much variability (ie, fewer than three studies in each subgroup) or too little variability (all studies took place in a hospital setting, or combined hospital and primary care setting). Forest plots for all subgroup analyses are presented in

796

e-Figure 2. However, these results were generally inconclusive and therefore are not discussed further in this article. In addition, we would have liked to include a subgroup analysis based on adherence as this factor has been noted to be important in COPD care.58 However, it was not reported in enough detail to allow for subgroup analysis.

Discussion

851

An overview of findings along with the justification for quality of evidence ratings is presented in Table 3. These findings suggest that CPWs for COPD have the potential to reduce complications (very low quality of evidence), reduce readmissions (high quality of evidence), and reduce length of stay (low quality of evidence). Furthermore, they did not point toward changes in mortality (low quality of evidence) or quality of life (low quality of evidence).

852 853 854 855 856 857 858 859 860 861 862

Complications

863

Meta-analysis showed a substantial reduction in odds of complication in the CPW group compared with the

864 865

811

866

812

CPW Study or Subgroup Mean SD

813 814

Ban 2012 Ko 2014 Ko 2017 LaRoche 2016 Santamaria 2004 Vanhaecht 2016

815 816 817 818 819 821 822 823 824 825

print & web 4C=FPO

820

5.83 9.09 7.41 2.96 6.71 11.65

Non-CPW Mean Difference Total Mean SD Total Weight IV, Random, 95% CI

1.92 95 7.31 2.75 98 12.1 185 12.17 9.14 185 11.29 90 12.21 12.87 90 2.3 74 4.37 6.5 68 4.3 88 7.6 7 90 10.36 115 13.36 14.49 84

867

Mean Difference IV, Random, 95% CI

868 869

54.0% –1.48 (–2.15, –0.81) 9.1% –3.08 (–5.27, –0.89) 3.7% –4.80 (–8.34, –1.26) 15.4% –1.41 (–3.04, 0.22) 14.3% –0.89 (–2.59, 0.81) 3.5% –1.71 (–5.34, 1.92)

870

647 Total (95% CI) 615 100.0% –1.66 (–2.35, –0.97) Heterogeneity: τ2 = 0.11; χ2 = 5.75, df = 5 (P = .33); I2 = 13% Test for overall effect: z = 4.72 (P < .00001) –10

876

871 872 873 874 875 877

–5 0 5 10 Favors [Experimental] Favors [Control]

Figure 5 – Forest plot for length of stay. See Figure 2 legend for expansion of abbreviation.

8 Original Research

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880

881

CPW Study or Subgroup Mean SD

882 883

Casas 2006 Ko 2017 Kruis 2014

884 885 887 888 889 890 891

print & web 4C=FPO

886

892

–13.7 15.62 –6.2 17.4 –0.31 13.87

Non-CPW Total Mean SD 21 90 437

Mean Difference Total Weight IV, Random, 95% CI

–11.29 16.34 –1.1 16.6 –0.35 19.83

41 90 424

Total (95% CI) 548 555 Heterogeneity: τ2 = 4.38; χ2 = 3.51, df = 2 (P = .17); I2 = 43% Test for overall effect: z = 1.03 (P = .30)

936

Mean Difference IV, Random, 95% CI

937 938

14.3% –2.41 (–10.76, 5.94) 29.8% –5.10 (–10.07, –0.13) 55.9% 0.04 (–2.25, 2.33) 100.0%

939 940 941

–1.84 (–5.36, 1.68)

942 943

–10 0 10 20 –20 Favors [Experimental] Favors [Control]

944 945

Figure 6 – Forest plot for change in SGRQ affects score. SGRQ ¼ St. George’s Respiratory Questionnaire. See Figure 2 legend for expansion of other abbreviation.

893

usual care group (OR, 0.37; 95% CI, 0.21-0.65). However, due to very low quality of evidence, the authors have very low confidence in the effect size estimate.

895 896 897 898 899

The results align well with a nondisease-specific systematic review on the use of CPWs in hospital settings. The review concluded that CPWs have the potential to reduce in-hospital complications.26

900 901 902 903 904

Readmissions

905

Meta-analysis showed a substantial reduction in odds of readmission in the CPW group compared with the usual care group (OR, 0.62; 95% CI, 0.41-0.94). Due to high quality of evidence, the authors are very confident in the effect size estimate.

906 907 908 909 910 911

It is noteworthy that a statistically significant reduction was not observed when assessing unadjusted data for 30-day readmissions. This factor is important for future researchers as it shows that analysis of shortterm effects may be misleading because it may take time for the full benefit of the CPW to be realized. In line with these findings, a systematic review on CPWs for pediatric asthma59 and a nondisease-specific systematic review on the use of CPWs in hospital settings26 found no evidence of reduced hospital visits. In contrast, the reduction noted when assessing the

912 913 914 915 916 917 918 919 920 921 922 923

longest follow-up periods aligns with a review on the use of the chronic care model for COPD, which found a reduction in unscheduled admissions,60 as well as a more recent publication describing a program combining transitional care and long-term selfmanagement support.61

CPW Study or Subgroup Mean SD

926 927

Casas 2006 Ko 2017 Kruis 2014

928 929

935

print & web 4C=FPO

930

934

950 951 952 953 954 955

Mortality

957

Meta-analysis did not provide evidence to suggest that odds of mortality differed between the CPW group and the usual care group. As a result of low quality of evidence, the authors have limited confidence in the effect size estimate.

958 959 960 961 962 963

These results align with the review by Rotter et al, which did not note a reduction in mortality resulting from CPW implementation. This finding is further replicated in reviews on the use of disease management programs for COPD that did not identify any change in mortality rates.62,63

964

Length of Stay

972

26

965 966 967 968 969 970 971

Meta-analysis revealed a meaningful reduction in length of stay in the CPW group compared with the usual care group (MD, –1.66; 95% CI, –2.35 to –0.97). However, due to low quality of evidence, the authors have limited confidence in the effect size estimate.

973 974 975 976 977 978 979

925

933

949

956

924

932

947 948

894

931

946

Non-CPW Total Mean SD

Mean Difference Total Weight IV, Random, 95% CI

–24.4 19.68 21 –17.11 24.44 41 –10.2 22.5 90 –3.2 21.3 90 –0.75 20.17 437 0.22 20.48 424

980

Mean Difference IV, Random, 95% CI

981 982

13.8% –7.29 (–18.55, 3.97) 30.2% –7.00 (–13.40, –0.60) 56.0% –0.97 (–3.69, 1.75)

Total (95% CI) 548 555 100.0% Heterogeneity: τ2 = 8.27; χ2 = 3.73, df = 2 (P = .15); I2 = 46% Test for overall effect: z = 1.53 (P = .13)

983 984 985

–3.66 (–8.35, 1.02)

986 987

–20 –10 0 10 20 Favors [Experimental] Favors [Control]

988 989 990

Figure 7 – Forest plot for change in SGRQ symptoms score. See Figure 2 and 6 legends for expansion of abbreviations.

9

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992

993

994

995

996

997

998

999

1000

1001

1002

1003

1004

1005

1006

1007

1008

1009

1010

1011

1012

1013

1014

1015

1016

1017

1018

1019

1020

1021

1022

1023

1024

1025

1026

1027

1028

1029

1030

1031

1032

1033

1034

1035

1036

1037

1038

1039

1040

1041

1042

1043

1044

1045

10 Original Research

TABLE 3

] Summary of Findings

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Risk Without CPW

Outcome

Risk With CPW

Absolute

Events/ Patients or Patients

Magnitude

Quality of Evidence

Comments Q32

Complications

78/249 (31.3%)

35/246 (14.2%)

169 fewer per 1,000 (from 85 fewer to 226 fewer)

0.37 [0.21, 0.65]

113/495 (3 studies)

Very low

Mixed RoB All studies lacked randomization

Readmissions

219/591 (37.1%)

164/588 (27.9%)

91 fewer per 1,000 (from 29 fewer to 147 fewer)

0.66 [0.49, 0.88]

383/1,179 (7 studies)

High

Effect significant when assessing studies with low RoB Effect significant when assessing randomized studies

Mortality

38/460 (8.3%)

40/454 (8.8%)

8 more per 1,000 (from 24 fewer to 56 more)

1.10 [0.69, 1.78]

78/914 (6 studies)

Low

Effect not significant when assessing studies with low RoB Mix of randomized and nonrandomized studies (sensitivity analysis not possible)

–1.66 [–2.35, –0.97]

1,262 (6 studies)

Low

Effect not significant when assessing studies with low RoB Mix of randomized and nonrandomized studies (sensitivity analysis not possible)

Q33

Length of stay

NA

NA

MD 1.66 days lower (2.35 lower to 0.97 lower)

Quality of life (SGRQ impacts)

NA

NA

MD 1.84 lower (5.36 lower to 1.68 higher)

–1.84 [–5.36, 1.68]

1,103 (3 studies)

Low

Lower score corresponds to better QoL Two studies with moderate RoB All studies randomized QoL measures showed high heterogeneity

Quality of life (SGRQ symptoms)

NA

NA

MD 3.66 lower (8.35 lower to 1.02 higher)

–3.66 [–8.35, 1.02]

1,103 (3 studies)

Low

Lower score corresponds to better QoL Two studies with moderate RoB All studies randomized QoL measures showed high heterogeneity

CPW ¼ clinical pathway; MD ¼ mean difference; QoL ¼ quality of life; SGRQ ¼ St. George’s Respiratory Questionnaire.

] 1047

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1051

1050

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1061

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1063

1065

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1067

1066

1069

1068

1071

1070

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1073

1075

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1077

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1079

1078

1081

1080

1082

1083

1085

1084

1087

1086

1089

1088

1091

1090

1092

1093

1095

1094

1097

1096

1098

1100

1099

1101

The significant reduction meshes well with a systematic review on CPWs for pediatric asthma59 as well as the aforementioned review by Rotter et al,26 which found that most studies reported a significant reduction in length of stay. However, it should be noted that heterogeneity prevented meta-analysis in the review by Rotter et al. Furthermore, results align with a systematic review on the use of chronic disease management programs for COPD, which noted a reduction in hospital days,64 and a review on the use of a chronic care model for COPD, which noted reduced hospital length of stay.60

1102 1103 1104 1105 1106 1107 1108 1109 1110 1111 1112 1113 1114 1115

Quality of Life

1116

Analysis of quality of life showed substantial heterogeneity, with only two of five planned analyses being feasible. Meta-analysis of change in SGRQ impacts and symptoms score did not show a significant difference (MD, –1.84 [95% CI, –5.36 to 1.68]; MD, –3.66 [95% CI, –8.35 to 1.02], respectively). As a result of low quality of evidence, the authors have limited confidence in both of the effect size estimates.

1117 1118 1119 1120 1121 1122 1123 1124 1125 1126

The absence of any change is consistent with reviews on the use of the chronic care model,60 integrated care,65 and chronic care management63 for patients with COPD, all of which found no change in quality. In contrast, an older review on the use of chronic disease management programs for patients with COPD found modest improvements regarding quality of life.62

1127 1128 1129 1130 1131 1132 1133 1134

Conclusions

1135 1136 1137 1138 1139 1140 1141 1142 1143 1144 1145

Q10

The current systematic review objectively found a number of benefits resulting from the implementation of CPWs for COPD. The results reveal high-quality evidence suggesting that CPWs for COPD have the potential to reduce readmissions. In addition, there is low-quality evidence to suggest that CPWs may reduce complications and length of stay regarding COPD. Finally, the evidence does not point to positive or negative changes to mortality rate or patient quality of

life were observed. Although these findings may suggest reduced health-care system resource use, additional research is needed in this area. It would be informative if future studies further investigated resource use, also taking into account cost of initial and maintenance implementation. The search strategy used to identify CPWs in primary Q11 care was expanded to include the following databases: CINAHL (Cumulative Index to Nursing and Allied Health Literature/EBSCO), World Health Organization International Clinical Trials Registry Platform, and clinicaltrials.gov. In addition, the searches were re-run in December 2017 and therefore do not end in 2015 as originally suggested. In the protocol, we suggested that we would conduct subgroup analysis based on the following outcomes: country where the study was conducted, year of publication, context for which the study was focused, and disease stage/severity. However, due to the limited number of studies and limited number of common Q12 outcomes, this approach was not feasible. We suggested financial data would be presented in US dollars; however, as only study presented financial information, this was left in EUR. As noted in the protocol, the search strategy used to identify CPWs in hospitals was only run for 2008 onward because this search was designed for a systematic review update rather than a new systematic review. The original reviewer included articles published up to the end of 2007. However, the review team used the references as well as a list of excluded studies from this review to identify publications focused on the use of CPWs before 2008. In addition, the search strategy utilized to identify studies focused on the use of CPWs in primary care had high sensitivity and identified many of the same studies identified by the search strategy for CPWs in hospitals. We are therefore confident that the search strategies provide an unbiased overview of the available literature.

1156 1157 1158 1159 1160 1161 1162 1163 1164 1165 1166 1167 1168 1169 1170 1171 1172 1173 1174 1175 1176 1177 1178 1179 1180 1181 1182 1183 1184 1185 1186 1187 1188 1189 1190 1191 1192 1193 1194 1195 1196 1197 1198 1199 1200

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1201

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Acknowledgments Q34 Q13 Q21

1214 1215 1216 1217 1218

Q18 Q19

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Q14

1227 1228 1229 1230 1231 1232 1233

Q22

1234 1235 1236 1237 1238 1239 1240 1241 1242 1243 1244 1245 1246 1247 1248 1249 1250

Q15

1251 1252 1253

Q20 Q16

1254 1255 1256 1257 1258 1259 1260 1261 1262 1263 1264 1265

Q17

Author contributions: D. D. M. and T. R. act as the guarantor of this research and take responsibility for the integrity of the work as a whole, from inception to published article. C. T. P., D. D. M., E. D. P., and T. R. made substantial contributions to conception and design. C. T. P., D. D. M., T. R., and S.-K. A. F. made substantial contributions to the acquisition of data. A. B., C. T. P., D. D. M., E. D. P., R. H., and T. R. made substantial contributions to analysis and interpretation of data. C. T. P., D. D. M., and T. R. drafted the submitted article. A. B., E. D. P., R. H., and S.-K. A. F. revised the article critically for important intellectual content. All authors provided final approval of the version to be published and agree to be responsible for all aspects of the work. Financial/nonfinancial disclosures: The authors have reported to CHEST the following: T. R. reports research funding (managed by the University of Saskatchewan) from Novartis Canada. E. D. P. reports receiving honoraria for advisory board participation from AstraZeneca, GlaxoSmithKline, and Boehringer Ingelheim; and consulting fees from AstraZeneca, outside the submitted work. D. D. M. reports the following: consultancy, Alberta Lung Association, AstraZeneca, Boehringer Ingelheim, Canadian Foundation for Healthcare Improvement, Chinese Committee of Health and Family Planning, GlaxoSmithKline, Health Canada, Lung Association of Saskatchewan, Novartis, Saskatchewan Ministry of Health, Saskatchewan Health Authority, and Yukon Health and Social Services; research funding (managed by the University of Saskatchewan), AstraZeneca, Boehringer Ingelheim, Canada Health Infoway, Canadian Institute of Health Research, GlaxoSmithKline, Lung Association of Saskatchewan, Lung Health Institute of Canada, Novartis, Sanofi, Saskatchewan Health Research Foundation, and ScheringPlough; and employee, University of Saskatchewan. None declared (C. T. P., M. R. H., S.-K. A. F.). Role of sponsors: The funding organization did not have any role in study design, data collection, data interpretation, data analysis, or manuscript writing. Other contributions: The authors thank Michelle Fiander, past trial search coordinator for the Cochrane EPOC group, for developing the original search strategies used in the Cochrane Systematic reviews on the use of CPWs in hospital and primary care, and Paul Miller, current trial search coordinator for the Cochrane EPOC group, for updating and re-running these searches. *Saskatchewan COPD CPWs Research Group Collaborators: Sheila Anderson, Margaret Baker, Zenon Belak, Nishen Bhagaloo, Terry Blackmore, Bree Calland, Hilda Chan, Patricia Comfort, Tania Diener, Ron Epp, Milo Fink, Carmen Johnson, Barb Konstantynowicz, Jayne Leibel, Winston Lok,

12 Original Research

Mohammed Moolla, Dodi Novak, Frank Offiah, Prakash Patel, Terry Ross, Ron Taylor, and Fouche Williams. Additional information: The e-Tables, e-Appendix, and e-Figures can be found in the Supplemental Materials section of the online article.

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21. McGlynn EA, Asch SM, Adams J, et al. The quality of health care delivered to adults in the United States. N Engl J Med. 2003;348(26):2635-2645.

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43. Casas A, Troosters T, Garcia-Aymerich J, et al. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J. 2006;28(1): 123-130.

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